This 510(k) webinar will help you understand the proposed changes to 510(k) process in 2011 and the regulatory process of implementing it.This 520(k) webinar will address both sides of the proposed changes. We will discuss how the expected change will affect device makers in terms of additional cost, affect on number of devices cleared, what is the regulatory process for implementing the changes. We will also discuss what industry has to prepare for the statutory changes coming in 2011.
Areas Covered in the Seminar:- Redefinition of terms such as Intended Use/Indications for Use, limiting use of predicates, consideration of off-label uses, greater authority to rescind 510(k)s and other changes.
- Understand recommendation for a new subclass of Class 2 products for which clinical studies will be required.
- Learn of possible changes in the de novo process that could streamline the clearance process.
- Obtain latest recommendations and comments from various device trade groups.
- How will the expected changes affect device makers?
- What additional costs might device makers face in light of new regulatory requirements?
- What will the proposed changes mean for the number of devices cleared?
- How will the proposed changes affect so-called "split-predicates"?
- What is the regulatory process for implementing the recommendations?
- What can device companies do to prepare for upcoming changes?
- Industry needs to prepare for these likely statutory changes in 2011
Who Will Benefit:This webinar will provide valuable assistance and guidance to device and IVD companies involved in any aspect of the 510(k) process. Employees who will benefit include:
- All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the proposed changes
- Regulatory Affairs/RA Specialists
- Clinical Affairs
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Engineering/Technical Services/Operations
- Consultants
